·~ALBEMARLE® -Albemarle Corporation 

451 Florida Street Telephone: 225-388-8011 

Baton Rouge, Louisiana 70801-1765 Facsimile: 225-388-7686 20' 2 -" I2 Ail 9: '7 

May 30,2012 

VIA OVERNIGHT MAIL 

Document Control Office (7407M) 


Office of Pollution Prevention and Toxics (OPPT) 


Environmental Protection Agency 


1201 Constitution Ave_, N.W. 


Washington, DC 20004-3302 .. , ' 


Attn: TSCA Section 4 

In compliance with the final rule, "Testing of Certain High Production Volume Chemicals; Second 


Group of Chemicals", 76FR 1067, January 17, 2011, Albemarle Corporation submits this outline 


Study Plan for "Benzenediamine, ar,ar-diethyl-ar-methyl-", CAS number 68479-98-1. 


i) Identity of the test rule 


"Testing of Certain High Production Volume Chemicals; Second Group of Chemicals", 76FR1067, 


January 17, 2011 


ii) Specific test requirements of the rule covered by the study plans. 


This study plan addresses the following end points: 


F1 - Developmental Toxicity Study 

iii) and A) The names and addresses of the test sponsors are provided below. 

Albemarle Corporation 

451 Florida Street 

Baton Rouge, LA 70801-1765 

Lonza Inc. 

90 Boroline Road 

Allendale, NJ 07401 USA 

B) The name, address, and telephone numbers of the project manager in the sponsor 

organization. 

Sylvia Jacobi 

Albemarle Corporation 

Parc Scientifique Einstein 

Rue de Bosquet 9 

B-1348 Louvain-Ia-Neuve, Belgium 

Tel: 3210481711 

11111111111 1111111111111111111111111 11111111111111111111 11111111 

401 200 000 7 2 

Fax: 3210481717 

Sylvia.Jacobi@albemarle.com 

C) The name, address, and telephone number of the appropriate individual to contact for oral 

and written communications with EPA is: 

CONTAINS NO CBI 
Kim Boudreaux 

Albemarle Corporation 20 J2 '-. p .'. I _ I? nIl.." ;\" Q. 1-' 

451 Florida Street 

Baton Rouge, LA 70801-1765 

Tel: 225-388-7776 

Fax: 225-388-7046 

Email: KimBoudreaux@albemarle.com 

D) 1) Name and address of testing facility, administrative official, and project managers. 

TNO Triskelion 

Utrechtseweg 48, 

3704 HE Zeist 

The Netherlands 

Tel: +31 888669284 

The Study Director is J.G. theuns -van Vliet 

2) The Curriculum Vitae for persons involved with the studies will be provided for the definitive 

study. 

ivThe identity of the test substance is "Benzenediamine, ar, ar-diethyl-ar-methyl" (CAS No. 

68479-98-1). The same test article used for all other studies under this test rule will be used for 

this study. The material is commercial DETDA with 97.27% purity 

v) A protocol for each proposed test is attached. 

F1 - Developmental Toxicity Study 

Please find attached an outline protocol for the dose range finding study for developmental 

affects. 

vi) This study is scheduled to begin on June 6,2012.. 

If you have any questions, please contact me and at the number provided above. 

Sincerely, 

~~h~ Kim A. Boudreaux 

Sr. Advisor, Regulatory Affairs 

cc: Wayne Chu (via email) 
Outline Protocol 1/2 

Dose range finding study for developmental toxicity study in rats (OECD 414) 

Study number 20193DRF -rNOtriskelion bv 

Dose range finding study for developmental toxicity study in rats 

Guideline non GLP 

Objective Dose range finding study to select dose levels for the subsequent main oral developmental 

toxicity study toxicity study in the same species. 

Groups Group Number of 

mated 

females 

6 

6 

6 

6 

One control group and three test groups administered different dose levels of the test 

substance; 6 mated females per group. 

Route of administration Oral via diet 

Housing Female rats will be housed individually during gestation in macrolon cages. 

Species Mated female Wistar rats (RccHanT!II: Wist, Harlan), The Netherlands; approximately 12 

weeks of age at start. 

Diet Commercial rodent diet (Rat & Mouse No.3 Breeding diet. RM3), ad libitum 

Treatment Daily administration of the test substance via diet during gestation from the start of 

gestation (day 1) until sacrifice (gestation day 21). 

Stability, homogeneity and content of the test substance in the carrier 

Analysis to demonstrate content of the test substance in the carrier will be performed. 

During the dose range finding study the method of analysis will be validated. 

Clinical observations 

General clinical observations: daily; morbidity is checked again in the afternoon (weekends 

and public holidays one check per day). 

Body weight Forfemales during gestation: gestation days 1,3,7, 10, 14, 17, and 21. 

Food consumption Forfemales during gestation: gestation days 1,3,7, 10, 14, 17, and 21. 

Ophthalmoscopsy 

Opthalmoscopy will be performed around day 2 of gestation in all animals and prior to 

necropsy on gestation day 21. Special attention will be paid to cataract. 

Sacrifice and necropsy parameters 

On gestation day 21 the animals will be sacrificed and caesarean section will be 

performed. The following parameters will be examined: 

uterus weight, containing placentas and embryos 

number of corpora lutea 

number of implantation sites 

number of early and late resorptions 

number of live and dead fetuses 

number of grossly visible malformed fetuses and fetuses with external abnormalities 

ovary weight 

TNO Triskelion bv 
2/2 

i 

Outline Protocol 

Dose range finding study for developmental toxicity study in rats (OECD 414) 

Study number: 20193DRF -rNOtriskelion bv 

gross evaluation of the placentas 

abnormal tissue or organs in dams 

histopathology will be performed on the pancreas of the dams 

Clinical Chemistry 

At autopsy blood will be collected from all animals for determination of transaminases and 

gamma-GT. 

Haematology 

At autopsy blood will be collected from all animals for haematology determinations 

including platelet and lymphocyte count. 

Fetal pathology 

Fetal pathology will not be performed in the dose range finding study. 

Calculated parameters 

Post-implantation loss 

Time schedule: 

Start of the study (arrival of the animal): 8 juni 2012 

Sacrifice (all animals): 28 june 2012 

Authorization 

C8:J Study Director J.G. Theuns - van Vliet 


Signature: Date: ........................ (dd-mm-yyyy) 


C8:J Sponsor 

Name company: 


Albemarle 


Name contact person: 


S. Jacobi 

Signature: 

Date: ........................ (dd-mm-yyyy) 


TNO Triskelion bv 
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